Drug recall: Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by…

Class II FDA enforcement event 79969. Recall start date: 20 Apr 2018. Status in the FDA record: Terminated. Termination date: 4 Jun 2020.

Reason for recall, in the words of FDA

Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Exela Pharma Sciences LLC started this drug recall on 20 Apr 2018. The firm address in the FDA record is in Lenoir, NC. FDA put the recall in Class II. FDA event 79969 has 1 product record. The first FDA enforcement report date is 30 May 2018. The record gives the status Terminated, with the termination date 4 Jun 2020.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA and Puerto Rico

Recalling firm

Exela Pharma Sciences LLC, Lenoir, NC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 79969: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0826-2018	Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.	5256 bottles	Class II	Terminated	30 May 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class II: 60%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Exela Pharma Sciences LLC
Initiated	Product (first record)	Type	Class	Records
30 Jul 2025	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx O	Drug	Class II	1
7 Mar 2025	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou	Drug	Class II	1
18 Oct 2023	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca	Drug	Class I	3
28 Nov 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,	Drug	Class I	2
4 Oct 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials,	Drug	Class I	2
11 Jan 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: E	Drug	Class II	1
5 May 2020	Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Scien	Drug	Class III	1

Exela Pharma Sciences LLC: all 8 events

Official channels

FDA enforcement report D-0826-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 79969. https://recallregister.com/fda/ii/79969/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA and Puerto Rico
What quantity of product is in FDA event 79969?: The FDA record gives this quantity: 5256 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.